Warning letter
Abaxis Inc: warning letter of Apr 12, 2019
FDA warning letter 558421 · Office of Medical Device and Radiological Health Operations
Key facts
| Reference number | 558421 |
|---|---|
| Company | Abaxis Inc |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Apr 12, 2019 |
| Posted date | Apr 23, 2019 |
| Issuing office | Office of Medical Device and Radiological Health Operations |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(i), 820, 807.81(b) |
| Inspection city | Union City |
| Inspection ZIP | 94587 |
| Inspection start date | Apr 9, 2018 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: